Market News & Trends
Longeveron Announces Positive Type C Meeting With FDA Regarding Pathway to BLA
Longeveron Inc. recently announced the positive Type C meeting with the US FDA supporting the advancement of Lomecel-B, a proprietary, scalable, allogeneic, investigational cellular therapy…
Denali Therapeutics Announces Successful Meeting With FDA
Denali Therapeutics Inc. recently announced the outcome of a recent successful meeting with the Center for Drug Evaluation and Research (CDER) division of the US…
West Completes $80-Million Manufacturing Expansion to Support Diabetes & Obesity Treatments for Patients Worldwide
West Pharmaceutical Services, Inc. recently announced it has completed an $80-million capacity expansion at its Contract Manufacturing site in Grand Rapids, MI. This investment will…
Nuvectis Pharma Announces Orphan Drug Designation for the Treatment of ARID1a-Deficient Ovarian, Fallopian Tube & Primary Peritoneal Cancers
Nuvectis Pharma, Inc. recently announced that NXP800 was granted Orphan Drug Designation by the US FDA for the treatment of AT-rich interactive domain-containing protein 1a…
Purdue Researchers Take Inspiration From Viruses to Improve Delivery of Nucleic Acid-Based Therapies to Cancer Cells
A researcher in Purdue University’s College of Science is developing a patent-pending platform technology that mimics the dual-layer structure of viruses to deliver nucleic acid (NA)-based…
ENA Respiratory Progresses Phase 1b Study of its Dry Powder Formulation of Intranasal Innate Immunomodulator
ENA Respiratory recently announced it has advanced its Phase 1b study of its dry powder formulation of INNA-051 to enable clinical progression of an improved…
COSCIENS Biopharma Announces Top-Line Results of Phase 3 Trial for the Diagnosis of Childhood-Onset Growth Hormone Deficiency
COSCIENS Biopharma Inc. recently announced the top-line results of its Phase 3 safety and efficacy study AEZS-130-P02 (the DETECT-trial) evaluating macimorelin for the diagnosis of…
Ocean Biomedical Announces Patent Issued for PfGARP Malaria Antibodies
Ocean Biomedical recently announced its Scientific Co-founder Dr. Jonathan Kurtis, MD, PhD, has been issued a key US patent for his groundbreaking malaria therapeutic antibody…
Medicus Pharma Announces First Patient Randomized in Phase 2 Trial of SKNJCT-003 for the Treatment of Nodular Basal Cell Carcinoma in Adults
Medicus Pharma Ltd. recently announced the enrollment of the first patient in its Phase 2 clinical trial SKNJCT-003 for the treatment of nodular basal cell…
Sermonix Pharmaceuticals Completes Enrollment of Phase 2 I-SPY 2 Arm Evaluating Lasofoxifene in Neoadjuvant Breast Cancer Setting
Sermonix Pharmaceuticals Inc. and Quantum Leap Healthcare Collaborative recently announced Sermonix completed enrollment of its Phase 2 clinical trial evaluating lasofoxifene, its lead investigational drug,…
SciSparc Submitted IND Application to the FDA for SCI-110 Phase 2b Clinical Trial for Patients With Tourette Syndrome
SciSparc Ltd. recently announced the submission of an Investigational New Drug (IND) application with the US FDA for its Phase 2b clinical trial for its…
First Patient Dosed with LIXTE’s LB-100 in New Clinical Trial to Treat Colorectal Cancer
LIXTE Biotechnology Holdings, Inc. recently announced the dosing of the first patient in a new clinical trial in collaboration with the Netherlands Cancer Institute (NKI)…
Galapagos Announces FDA Clearance of IND Application for Phase 1/2 ATALANTA-1 Study of CD19 CAR-T, GLPG5101, in Relapsed/Refractory Non-Hodgkin Lymphoma
Galapagos NV recently announced the US FDA has cleared its Investigational New Drug (IND) application for ATALANTA-1, a Phase 1/2 multicenter study evaluating the feasibility,…
AiViva Biopharma Completes Enrollment in a Phase 1 Clinical Trial for Age-Related Macular Degeneration & Diabetic Macular Edema
AiViva Biopharma Inc. recently announced it has fully enrolled and completed dosing the last patient in a Phase 1 trial with wet age-related macular degeneration…
Brains Bioceutical Set to Achieve One of the World’s First CEP for Cannabidiol Certification With the European Directorate for the Quality of Medicines & Healthcare
Brains Bioceutical Corp. (BBC) has achieved a groundbreaking milestone by submitting one of the world’s first CEP (Certification of Suitability) application for its Cannabidiol (CBD)…
Abata Therapeutics Receives FDA Fast Track Designation for Progressive Multiple Sclerosis Treatment
Abata Therapeutics recently announced the US FDA has granted Fast Track designation for ABA-101 for the treatment of patients with progressive multiple sclerosis (MS). The…
Emergex Receives Patent Protection for First-in-Class Influenza A Vaccines With Potential to Provide Long-Term T Cell Immunity
Emergex Vaccines Holding Limited recently announced it has received patent protection from the United States Patent and Trademark Office (USPTO) for its novel class of…
Ingenza Announces Partnership With Cellugy to Investigate the Potential of Biofabricated Cellulose
Industrial biotech specialist Ingenza recently announced it is collaborating with Cellugy to accelerate the development of its innovative platform for producing biofabricated cellulose. This technology…
PCI Pharma Services’ Bedford, NH Location Successfully Completes International Coalition of Medicines Regulatory Authorities Inspection
PCI Pharma Services (PCI), a leading global contract development and manufacturing organization (CDMO), has successfully completed the International Coalition of Medicines Regulatory Authorities (ICMRA) inspection…
SGS Introduces New Specialized Bioanalytical Testing Services in North America
SGS, the world’s leading testing, inspection and certification company, announces the introduction of new specialized bioanalytical testing services in the North American pharmaceutical and biopharmaceutical…
